Efficacy of a new nutraceutical formulation: L-tryptophan, probiotics, charcoal, chamomile, mint, and licorice (COLONIR®) in the improvement of gastrointestinal symptoms in subjects with irritable bowel syndrome.

BACKGROUND: Irritable bowel syndrome (IBS) is one of the most common functional gastrointestinal disorders. IBS is characterized by recurrent chronic abdominal pain and altered bowel habits in the absence of organic damage. Although there are reviews and guidelines for treating IBS, the complexity and diversity of IBS presentation make treatment difficult. Treatment of IBS focuses on relieving symptoms as mild signs and symptoms can often be controlled by managing stress and by making changes in diet and lifestyle. The use of nutraceutical compounds has been advocated as a possible alternative treatment in patients with IBS. COLONIR® (Omega Pharma Srl, Milan, Italy) may be an alternative or adjuvant treatment in patients with gastrointestinal symptoms. This study aimed to evaluate the effect of this new nutraceutical formulation in inducing symptoms remission and improve gastrointestinal habits. METHODS: An initial cohort of 1004 consecutive patients referred to 25 different Units of Internal Medicine a/o Gastroenterology in Italy to perform colonoscopy for intestinal symptoms was asked to participate. Patients were treated for 2 months with two doses of nutraceuticals/day during meals namely COLONIR®. Patients were assessed at baseline and after 2 months to evaluate the frequency and severity of gastrointestinal symptoms in the past seven days with a questionnaire based on ROMA IV criteria. RESULTS: After 2 months, 899 patients completed the follow-up. COLONIR® achieved a statistically significant reduction of severity of symptoms in the study population without any documented side effects. CONCLUSIONS: These promising results, here reported, need to be confirmed, valuating the efficacy of COLONIR® in relieving gastrointestinal symptoms in IBS patients in further studies.

Nickel sensitization in patients with gastro-esophageal reflux disease.

BACKGROUND: Gastro-esophageal reflux disease (GERD) leads to frequent medical visits, and available therapies fail in up to 40% of patients. Food allergies may be involved in GERD pathogenesis; however, allergens other than food have received little attention. Nickel allergy is common in the general population and some high-nickel foods are associated with GERD. However, the potential relationship between nickel allergy and GERD remains unaddressed. AIM: This study aimed to evaluate the prevalence of nickel sensitization in patients with and without GERD and to compare clinical and demographic features. METHODS: This prospective, multicenter study included 210 adult GERD patients and 140 patients without GERD who presented at the general practitioner. All GERD patients had undergone treatment with proton pump inhibitors and upper digestive endoscopy within the previous five years. Demographic and clinical data were collected by questionnaire and patients underwent a nickel patch allergy test. RESULTS: Patients with and without GERD presented similar characteristics, with the exception of nickel sensitization, which was significantly more prevalent among GERD patients than controls (39.5% vs. 16.4%; p = 0.001). Nickel-positive GERD patients were more frequently female (90.4% vs. 65.4%, p = 0.003) and asthmatic (18.1% vs. 4.7%; p = 0.038), compared to nickel-negative GERD patients. At six-month follow-up, most of the patients, with or without nickel sensitization, reported improved symptoms without differences in drug prescription. CONCLUSION: Nickel sensitization is particularly prevalent in GERD patients seen in general practice. Whether allergies other than food allergy play a role in GERD remains to be elucidated.

Utility of noninvasive methods for the characterization of nonalcoholic liver steatosis in the family practice. The "VARES" Italian multicenter study.

The diagnostic utilities of ultrasonography (US), fatty liver index (FLI) and an algorithm of nine serum markers (Fibromax) were evaluated in family practice to noninvasively characterize patients with nonalcoholic fatty liver disease (NAFLD). A multicenter study was conducted by enrolling 259 consecutively observed patients (age 51 ± 10 years) with clinical and ultrasonographic features of NAFLD . Patients had mild (16.2%), moderate (69.9%), or severe (13.9%) liver steatosis and 60.2% had hypertransaminasemia. The percent of patients with overweight, obesity, diabetes, hypertension, and dyslipidemia were 42.7%, 46.5% (4.2% severe obesity), 24.7%, 40.9%, and 56.4% , respectively. Lean patients (10.8%) had normal transaminases in two/thirds of the cases. A multivariate logistic regression (including age > 50 yrs, BMI > 30 kg/m2, HOMA > 3, and hypertransaminasemia) identified 12.3% of patients at risk for steatohepatitis. With a sensitivity of 50% and specificity of 94.7%, Fibromax identified 34 patients (13.1%) with likely advanced fibrosis and found that over 28% of patients with moderate (ultrasonographic) steatosis were likely to be carrying severe steatosis. Steatotest score was significantly associated with BMI, waist circumference, ALT, triglycerides, and FLI. Fibrotest correlated only with ALT. FLI identified 73.4% of patients as likely to be carrying a fatty liver. In conclusion, NAFLD should be systematically searched and characterized in all patients with metabolic disturbances and cardiovascular risk. Asymptomatic subjects at risk also should be screened for NAFLD. Fibromax is a promising noninvasive diagnostic tool in family medicine for identifying patients at risk for NAFLD who require targeted follow-up.